NCT06967558 The Role of Islet GLP-1 in the Pathogenesis of Prediabetes
| NCT ID | NCT06967558 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-11-01 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
We recently demonstrated that blockade of Glucagon-Like Peptide-1's (GLP-1) receptor (GLP1R) results in changes in islet function without changes in circulating GLP-1. These effects are more pronounced in people with early type 2 diabetes (T2DM) in keeping with increased expression of PC-1/3 and GLP-1 that is observed in diabetic islets. However, its regulation is at present unknown. At present it is unknown if these abnormalities develop in prediabetes and whether they contribute to the phenotypes observed. In this experiment we will use blockade of GLP1R to probe the contribution of endogenous GLP-1 secretion to the regulation of fasting glucose and islet function in prediabetes.
Eligibility Criteria
Inclusion Criteria: * People with stable weight and no history of diabetes. * Fasting glucose \< 126 mg/dL * 2hr glucose after 75g OGTT \< 200 mg/dL Exclusion Criteria: * Age \< 25 or \> 70 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose). * HbA1c \> 6.5% * Use of any glucose-lowering agents including metformin or sulfonylureas. * For female subjects: positive pregnancy test at the time of enrollment or study * History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease.
Contact & Investigator
Adrian Vella, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06967558 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 70 Years, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06967558 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06967558 currently recruiting?
Yes, NCT06967558 is actively recruiting participants. Contact the research team at vella.adrian@mayo.edu for enrollment information.
Where is the NCT06967558 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06967558 clinical trial?
NCT06967558 is sponsored by Mayo Clinic. The principal investigator is Adrian Vella, MD at Mayo Clinic. The trial plans to enroll 60 participants.
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